Everything You Need to Know About Reimbursement For GUIDE Everything You Need to Know About Reimbursement For OMIDRIA

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REIMBURSEMENT GUIDEEverything You Need to Know About Reimbursement For OMIDRIA2About OMIDRIAOMIDRIA is the first and only FDA-approved drug that provides continuous intracameral delivery of NSAID and mydriatic/ anti-miotic therapy during cataract surgery1 OMIDRIA contains a non-steroidal anti-inflammatory drug, ketorolac, to prevent miosis and to reduce postoperative pain and an a1-adrenergic receptor agonist, phenylephrine, to maintain ocular pupil diameter OMIDRIA is easy to integrate into operating procedures: Added preoperatively to irrigation solution1 No other preparation required OMIDRIA is supplied as a concentrate in a clear, glass, single-patient-use vial containing 4-mL of sterile solution1 OMIDRIA is reimbursed per vial, not per mL. Therefore, providers should use one vial as the billing unitINDICATIONS AND USAGEOMIDRIA is added to ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.IMPORTANT SAFETY INFORMATIONOMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% must be added to irrigation solution prior to intraocular use.OMIDRIA is contraindicated in patients with a known hypersensitivity to any of its ingredients. Systemic exposure of phenylephrine may cause elevations in blood pressure.Use OMIDRIA with caution in individuals who have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs), or have a past medical history of asthma.Please see the Full Prescribing Information for OMIDRIA.About This GuideThis guide provides information on pass-through, OMIDRIA coding, OMIDRIA reimbursement, and more This guide is designed to facilitate timely reimbursement by standardizing claim submissions and ensuring appropriate reimbursement through proper billing and product coding* Coverage and payment may vary by payer, contractual agreements, and site of service* Information contained in this guide is provided as a reference for obtaining appropriate and accurate reimbursement for the use of OMIDRIA in eligible patients. Omeros does not guarantee reimbursement. OMIDRIAssure program services are subject to change without notice.OMIDRIA has a unique billing codeC9447 Injection, phenylephrine and ketorolac, 4 ml vial Important reminders The OMIDRIAssure comprehensive reimbursement program provides assistance for financially eligible uninsured or government-insured patients and those with insufficient commercial insurance* Questions related to a patients benefits or eligibility for cataract surgery or OMIDRIA should be addressed by calling the OMIDRIAssure Live Assistance Information Hotline at 1-877-OMIDRIA (1-877-664-3742), contacting your Omeros representative, or working directly with your payer provider representative Consult your facility-specific payer contracts to determine whether OMIDRIA is paid separately from the packaged payment for cataract surgeryIMPORTANT SAFETY INFORMATION The most commonly reported adverse reactions at 2-24% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation.Use of OMIDRIA in children has not been established.Please see the Full Prescribing Information for OMIDRIA.You are encouraged to report Suspected Adverse Reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.4Medicare Part B Pass-through status allows reimbursement for OMIDRIA separate from the packaged Ambulatory Payment Classification (APC) reimbursement for the surgical procedure For pass-through drugs, Centers for Medicare & Medicaid Services (CMS) sets the payment rate at Average Selling Price (ASP) plus 6% Check the CMS website for current quarterly payment rates in the Hospital OPPS (Addendum B) or ASC Payments (Addendum BB) section Payment rates are updated quarterly by CMS and, during the government sequester, 6% is reduced to 4.3% There is no patient co-payment for OMIDRIA in the HOPD setting. In the ASC setting, the patient may be subject to a 20% co-payment Approximately 90% of Medicare Part B patients have some form of supplemental/secondary insurance that covers co-payments3, For government-insured patients with an uncovered out-of-pocket expense and who meet certain financial criteria, Omeros has established the Equal Access Patient Assistance Program as part of OMIDRIAssure, which allows patients to receive OMIDRIA at no cost; a free vial is sent to your facility prior to surgery About Medicare Billing and ReimbursementPass-through status for OMIDRIA allows ASCs and HOPDs to bill Medicare and other payers for OMIDRIA using a Healthcare Common Procedure Coding System (HCPCS) code unique to OMIDRIA C9447 Injection, phenylephrine and ketorolac, 4 ml vial. The payment is over and above the facility fees paid to ASCs or to HOPDs for cataract surgery.CY 2017 HCPCS and APC codes for OMIDRIA2CY 2017 HCPCS CY 2017 long descriptor CY 2017 APCC9447 Injection, phenylephrine and ketorolac, 4 ml vial 1663*Status Indicator Based on currently available information and subject to change without notice. Individual plan coverage, policies, and procedures may vary and should be confirmed. Omeros does not guarantee coverage or payment. To be eligible for the Equal Access Patient Assistance Program, patients must be enrolled prior to surgery. For any patient eligible for the Equal Access Patient Assistance Program, (1) the facility receives a free vial of OMIDRIA prior to surgery and (2) the patients insurance carrier(s) should not be billed for OMIDRIA. OMIDRIAssure program services are subject to change without notice. Please see the Full Prescribing Information for OMIDRIA.Medicare Part C (Medicare Advantage) Like traditional Medicare Part B, Medicare Advantage plans will cover OMIDRIA, but the payment rate may differ from traditional Part B or be subject to payer-specific facility contractual limitations For a Medicare Advantage patient, the specific Medicare Advantage payer should be contacted in advance to determine the level of reimbursement for OMIDRIA About Medicare Billing and Reimbursement* To be eligible for the Equal Access Patient Assistance Program, patients must be enrolled prior to surgery. For any patient eligible for the Equal Access Patient Assistance Program, (1) the facility receives a free vial of OMIDRIA prior to surgery and (2) the patients insurance carrier(s) should not be billed for OMIDRIA. OMIDRIAssure program services are subject to change without notice.EQUAL ACCESS PATIENT ASSISTANCE PROGRAM*Assistance for financially eligible uninsured or government-insured patients Eligible patients* will receive OMIDRIA at no cost Free vial will be sent to your facility prior to surgery Application for free vial must be submitted 5 days prior to date of surgery Please visit www.OMIDRIAssure.com for more details and to start enrolling patients today For personalized help, call the OMIDRIAssure Live Assistance Information Hotline at 1-877-OMIDRIA (1-877-664-3742) 9 am6 pm ET, MondayFriday6 About Commercial Insurance Billing and Reimbursement Check if facility-specific payer contracts allow for separate payment of drugs, new technologies, and pass-through drugs Confirm and verify payer payment/fee schedules for OMIDRIA Verify acceptance of C-code and payer-specific use of appropriate revenue codeWE PAY THE DIFFERENCE COMMERCIALLY INSURED PATIENT REIMBURSEMENT PROGRAMAssistance for patients with insufficient commercial insurance Omeros will pay your facility, on behalf of your patient, the difference between your facilitys acquisition cost for OMIDRIA and the amount covered by your patients insurance* The benefits of OMIDRIAssure apply even if the annual commercial deductible obligation has not yet been met Please visit www.OMIDRIAssure.com for more details and to start enrolling patients today For personalized help, call the OMIDRIAssure Live Assistance Hotline at 1-877-OMIDRIA (1-877-664-3742) 9 am6 pm ET, MondayFridayPayer Contracts: Best Practices for Medicare Advantage** and Commercial Payers* OMIDRIAssure program services are subject to change without notice. The We Pay The Difference Commercial Reimbursement Program patient benefit is not available for patients with any government insurance. Omeros does not guarantee reimbursement.** Coverage and payment varies by Medicare Advantage plans.Please see the Full Prescribing Information for OMIDRIA.Helpful hints: best practices for claim submissions in general Make sure submissions are timely and accurate Double-check codes and units Verify Diagnosis codes and procedure codes CPT, HCPCS, and revenue codes NDC (depending on claim form) Stay up to date on the payer and billing and coding trends Pay close attention and double-check your work when creating claims Follow up with payers after claims are submitted About Commercial Insurance Billing and ReimbursementPatient insurance benefits should be thought of in terms of primary and additional coverage to determine billable status Work with Omeros Reimbursement Team to determine billable status for your payers Step 1: Primary InsuranceStep 2: Additional InsuranceMedicare C(Replacement or) Advantage)Medicare B(FFS or Legacy Medicare)Medicare Supplemental (Medigap)SecondaryMedicaidOtherCommercialSecondaryMedicare Part A/BOther GovernmentMedicaidTricare / DOD Ambulatory Surgery Center Sample CMS-1500 Paper Claim FormAPPROVED OMB-0938-1197 FORM 1500 (02-12) PLEASE PRINT OR TYPEInformation contained herein is provided as a reference for obtaining appropriate and accurate reimbursement. This content is for informational purposes only. Omeros does not guarantee that the use of the recommended codes will result in reimbursement. Providers may always contact the payer directly with reimbursement or billing questions. Contact 1-844-OMEROS1 (1-844-663-7671) for more information about how to submit for OMIDRIA reimbursement.CPT is a registered trademark of the American Medical Association.CPT = Current Procedural Terminology; ICD-10-CM = International Classification of Diseases, Tenth Revision, Clinical Modification; IOL = intraocular lens; NDC = National Drug Code.Item 24D: Enter the unique Billing Code for OMIDRIAItem 24D: Enter the applicable procedure code (e.g., 66984 for cataract surgery)Item 21: Enter the Diagnosis Code(s) Item 24B: 24 indicates an ASCEnter all applicable patient informationIf using miscellaneous J-code instead of using C-code for OMIDRIA based on instruction from payer, please include NDC on line 19Item 24G: Enter the number of Units (vials)Item 24F: Enter price for OMIDRIA from price schedule, including all applicable mark-upsItem 33a: Entry of NPI Number is requiredItem 24D: Enter the Modifier for left eye (LT) or right eye (RT)Item 21: Enter 0 if using ICD-10-CM04 01 2017 04 01 2017 24 66984 LT A XXX XX 1 1234567890 .XXXXXX XX123 45 6789ASMITH, MARY123 MAINANYTOWN PAANY ASC456 ANY STREETPHILADELPHIA, PA 1910304 01 2017 04 01 2017 24 C9447 A XXX XX 1 1234567890123 456-78900NDC# 62225-0600-048 Sample UB-04 Paper Claim FormInformation contained herein is provided as a reference for obtaining appropriate and accurate reimbursement. This content is for informational purposes only. Omeros does not guarantee that the use of the recommended codes will result in reimbursement. Providers may always contact the payer directly with reimbursement or billing questions. Contact 1-844-OMEROS1 (1-844-663-7671) for more information about how to submit for OMIDRIA reimbursement.CPT is a registered trademark of the American Medical Association.CPT = Current Procedural Terminology; ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM = International Classification of Diseases, Tenth Revision, Clinical Modification; IOL = intraocular lens; NDC = National Drug Code. __ __ __1 2 4 TYPEOF BILLFROM THROUGH5 FED. TAX NO.abcdDXECI12345678910111213141516171819202122231234567891011121314151617181920212223ABCA B C D E F G HI J K L M N O P Qa b c a b cab c dADMISSION CONDITION CODESDATEOCCURRENCE OCCURRENCE OCCURRENCE OCCURRENCE SPAN OCCURRENCE SPANCODE DATE CODE CODE CODE DATE CODE THROUGHVALUE CODES VALUE CODES VALUE CODESCODE AMOUNT CODE AMOUNT CODE AMOUNTTOTALSPRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE NPICODE DATE CODE DATE CODE DATEFIRSTc. d. e. OTHER PROCEDURE NPICODE DATE DATEFIRSTNPIb LAST FIRSTc NPId LAST FIRSTUB-04 CMS-1450710 BIRTHDATE 11 SEX 12 13 HR 14 TYPE 15 SRCDATE16 DHR 18 19 20FROM21 2522 26 2823 27CODE FROMDATEOTHERPRV ID THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.b .INFOBEN.CODEOTHER PROCEDURETHROUGH 29 ACDT 303231 33 34 35 36 3738 39 40 4142 REV. CD. 43 DESCRIPTION 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES 4952 REL51 HEALTH PLAN ID53 ASG.54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI5758 INSUREDS NAME 59 P.REL 60 INSUREDS UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO.64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME66 67 6869 ADMIT 70 PATIENT 72 7374 75 76 ATTENDING80 REMARKSOTHER PROCEDUREa77 OPERATING78 OTHER 79 OTHER 81CCCREATION DATE3a PAT.CNTL #24b. MED.REC. # 44 HCPCS / RATE / HIPPS CODEPAGE OFAPPROVED OMB NO. 0938-0997ea8 PATIENT NAME50 PAYER NAME63 TREATMENT AUTHORIZATION CODES6 STATEMENT COVERS PERIOD9 PATIENT ADDRESS17 STAT STATE DX REASON DX 71 PPS CODEQUALLASTLASTNational UniformBilling CommitteeNUBCOCCURRENCEQUALQUALQUALCODE DATEABCABCABCABCABCababXXX Refer to Payer Contract for Code C9447 1272 Sterile Supplies276 IOL V2632300 Laboratory360 Operating Room 66984370 Anesthesia 00142710 Recovery Room Any Hospital Any Hospital 123 Any Street 123 Any Street Philadelphia, PA 19103 Philadelphia, PA 19103John Doe 1234 Main Street Philadelphia, PA 19111Doe, John Philadelphia PA 191111234 98765 0131 1234 Main Street03 20 1971 M 01XXXX2222222222 2222222222 1G 1234569822 Smith DavidMedicareDoe, John 18 ABC1234567800 B3 282N00000X01 1Y YForm Locator 17: Enter Patient Status Enter all applicable patient informationForm Locator 4: Enter the 4-digit code that specifies place of service and submission type. For example, for HOPD, the first 3 digits are 013. The final digit is usually a 1, meaning one claim for the eventForm Locator 67: Enter the primary Diagnosis Code Form Locator 44: Enter the Procedure Code(s)Form Locator 42*: Enter the Revenue CodeForm Locator 44: Enter the unique Billing Code for OMIDRIAForm Locator 46: Enter the number of Units (vials)Form Locator 50A: If Medicare is the primary payer, enter Medicare on line AForm Locator 66: Enter 0 if using ICD-10-CMForm Locator 47: Enter price for OMIDRIA from price schedule, including all applicable mark-upsForm Locator 80: This is where NDC number should be placed if NOC code required or if Medicaid for 340B rebate requirementNDC# 62225-0600-04Please see the Full Prescribing Information for OMIDRIA.* Note: For hospitals and ASCs using UB04 form, it is a best practice to confirm with the payer correct revenue code to ensure reimbursement.2345810111512HASH - 04D LIGHT DARK1 1 12 1 23 1 34 2 15 2 26 2 37 3 18 3 29 3 30 1 4A=01B=12C=23D=34E=45F=56G=67H=78I=89J=00K=11L=22M=33N=44O=55P=66Q=77R=88S=99T=10U=21V=32W=43X=54Y=65Z=76HASHMARK BAR CODE GUIDEDate: 11/JUN/2015 PMS Item #: 014875 FILE NAME: 014875_OMEROS_INSERT.indd VERSION: 00BARCODE TYPE(S): 128 UPC I2of5 RSS14/DATABARBARCODE(S) TO READ: N/A FLEXO OFFSET OTHER: SPECIAL INSTRUCTIONS/NOTES:INK(S):PMS Graphics Print Name: Signature:PMS PSE Print Name: Signature:PMS Customer Print Name: Signature:PLEASE REVIEW CAREFULLY: Although every effort is made to ensure this artwork is correct, errors and omissions do occur. Patheon Manufacturing Services LLC does not assume any liability beyond the corrections needed. Patheon Manufacturing Services LLC is not responsible for copy or content, Patheon assumes 100% responsibility for machine attributes only.PMS XXXXPMS XXXXBLACKPMS XXXXPMS XXXXPMS XXXXFULL PRESCRIBING INFORMATION:1 INDICATIONS AND USAGEOmidria is added to an ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.2 DOSAGE AND ADMINISTRATIONOmidria must be diluted prior to intraocular use. For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.The storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions.Do not use if the solution is cloudy or if it contains particulate matter.3 DOSAGE FORMS AND STRENGTHSOmidria is a sterile solution concentrate containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial.4 CONTRAINDICATIONSOmidria is contraindicated in patients with a known hypersensitivity to any of its ingredients.5 WARNINGS AND PRECAUTIONS5.1 Elevated Blood PressureSystemic exposure of phenylephrine can cause elevations in blood pressure.5.2 Cross-Sensitivity or HypersensitivityThere is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatories (NSAIDs). There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac in patients who either have a known hypersensitivity to aspirin/NSAIDs or a past medical history of asthma. Therefore, use Omidria with caution in individuals who have previously exhibited sensitivities to these drugs.6 ADVERSE REACTIONS6.1 Clinical Studies ExperienceBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinicalstudies of another drug and may not reflect the rates observed in practice.Table 1 shows frequently reported ocular adverse reactions with an incidence of 2% of subjects as seen in the combined clinical trial results from three randomized, placebo-controlled studies.HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use OMIDRIA safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3%Initial U.S. Approval: 2014____________________ INDICATIONS AND USAGE _____________________OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis (1) Reducing postoperative pain (1)OMIDRIA is added to an irrigation solution used during cataract surgery or intraocular lens replacement.__________________ DOSAGE AND ADMINISTRATION __________________OMIDRIA must be diluted prior to use. For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of OMIDRIA is diluted in 500 mL of ophthalmic irrigating solution. Irrigation solution is to be used as needed for the surgical procedure. (2)_________________ DOSAGE FORMS AND STRENGTHS __________________OMIDRIA is a sterile solution concentrate containing 1% w/v of phenylephrine and 0.3% w/v ketorolac in a single-patient-use vial. (3)______________________ CONTRAINDICATIONS _______________________None. (4)__________________ WARNINGS AND PRECAUTIONS ___________________Systemic exposure of phenylephrine may cause elevations in blood pressure. (5.1)_____________________ ADVERSE REACTIONS _______________________The most common reported adverse reactions at 2-24% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Omeros Corporation at 1-844-OMEROS1 or www.omidria.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.See 17 for PATIENT COUNSELING INFORMATIONRevised: May 2016FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Elevated Blood Pressure5.2 Cross-Sensitivity or Hypersensitivity6 ADVERSE REACTIONS6.1 Clinical Studies Experience8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.3 Pharmacokinetics14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.Table 1: Ocular Adverse Reactions Reported by 2% of SubjectsMedDRA Preferred Term Placebo(N=462)Omidria(N=459)n (%) n (%)Ocular EventsAnterior Chamber Inflammation 102 (22%) 111 (24%)Intraocular Pressure Increased 15 (3%) 20 (4%)Posterior Capsule Opacification 16 (4%) 18 (4%)Eye Irritation 6 (1%) 9 (2%)Foreign Body Sensation in Eyes 11 (2%) 8 (2%)8 USE IN SPECIFIC POPULATIONS8.1 PregnancyTeratogenic Effects: Pregnancy Category CAnimal reproduction studies have not been conducted with Omidria or phenylephrine. It is also not known whether Omidria can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Omidria should be used in pregnant women only if clearly needed.Ketorolac, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses produced systemic exposure that is 1150 times and 4960 times the plasma exposure (based on Cmax) at the recommended human ophthalmic dose (RHOD), respectively. When administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (740 times the plasma exposure at the RHOD), ketorolac produced dystocia and increased pup mortality.Clinical Considerations:Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Detectable ketorolac plasma concentrations are available following ocular Omidria administration [see Clinical Pharmacology (12.3)]. The use of Omidria during late pregnancy should be avoided.8.3 Nursing MothersBecause many drugs are excreted in human milk, caution should be exercised when Omidria is administered to nursing women.8.4 Pediatric UseSafety and effectiveness of Omidria in pediatric patients below the age of 18 years have not been established.8.5 Geriatric UseNo overall differences in safety or effectiveness have been observed between elderly and adult patients.OMIDRIA PI100016 Revised: 05/201610Date: 11/JUN/2015 PMS Item #: 014875 FILE NAME: 014875_OMEROS_INSERT.indd VERSION: 00BARCODE TYPE(S): 128 UPC I2of5 RSS14/DATABARBARCODE(S) TO READ: N/A FLEXO OFFSET OTHER: SPECIAL INSTRUCTIONS/NOTES:INK(S):PMS Graphics Print Name: Signature:PMS PSE Print Name: Signature:PMS Customer Print Name: Signature:PLEASE REVIEW CAREFULLY: Although every effort is made to ensure this artwork is correct, errors and omissions do occur. Patheon Manufacturing Services LLC does not assume any liability beyond the corrections needed. Patheon Manufacturing Services LLC is not responsible for copy or content, Patheon assumes 100% responsibility for machine attributes only.PMS XXXXPMS XXXXBLACKPMS XXXXPMS XXXXPMS XXXX10 OVERDOSAGESystemic overdosage of phenylephrine may cause a rise in blood pressure. It may also cause headache, anxiety, nausea, vomiting, and ventricular arrhythmias. Supportive care is recommended.11 DESCRIPTIONOmidria is a sterile aqueous solution concentrate containing the 1-adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine.The descriptions and structural formulae are:Phenylephrine Hydrochloride Drug Substance:Common Name: phenylephrine hydrochlorideChemical Name: (-)-m-Hydroxy--[(methylamino)methyl]benzyl alcohol hydrochlorideMolecular Formula: C9H13NO2 HClMolecular Weight: 203.67 g/moleFigure 1: Chemical Structure for Phenylephrine HClKetorolac Tromethamine Drug Substance:Common Name: ketorolac tromethamineChemical Name: ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)Molecular Formula: C15H13NO3 C4H11NO3Molecular Weight: 376.40 g/moleFigure 2: Chemical Structure for Ketorolac TromethamineNDA 205388Page 9Omidria is a clear, colorless, sterile solution concentrate with a pH of approximately 6.3.Each vial of Omidria contains:Actives: phenylephrine hydrochloride 12.4 mg/mL equivalent to 10.16 mg/mL of phenylephrine and ketorolac tromethamine 4.24 mg/mL equivalent to 2.88 mg/mL of ketorolac.Inactives: citric acid monohydrate; sodium citrate dihydrate; water for injection; may include sodium hydroxide and/or hydrochloric acid for pH adjustment.12 CLINICAL PHARMACOLOGY12.1 Mechanism of ActionThe two active pharmaceutical ingredients (API) in Omidria, phenylephrine and ketorolac, act to maintain pupil size by preventing intraoperative miosis, and reducing postoperative pain.Phenylephrine is an 1-adrenergic receptor agonist and, in the eye, acts as a mydriatic agent by contracting the radial muscle of the iris. Ketorolac is a nonsteroidal anti-inflammatory that inhibits both cyclooxygenase enzymes (COX-1 and COX-2), resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma. Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, also prevents surgically induced miosis.12.3 PharmacokineticsIn a pharmacokinetic study evaluating Omidria, systemic exposure to both phenylephrine and ketorolac was low or undetectable.A single-dose of Omidria as part of the irrigation solution was administered in 14 patients during lens replacement surgery. The volume of irrigation solution used during surgery ranged between 150 mL to 300 mL (median 212.5 mL). Detectable phenylephrine plasma concentrations were observed in one of 14 subjects (range 1.2 to 1.4 ng/mL) during the first two hours after the initiation of Omidria administration. The observed phenylephrine plasma concentrations could not be distinguished from the preoperative administration of phenylephrine 2.5% ophthalmic solution prior to exposure to Omidria.Ketorolac plasma concentrations were detected in 10 of 14 subjects (range 1.0 to 4.2 ng/mL) during the first 8 hours after the initiation of Omidria administration. The maximum ketorolac concentration was 15 ng/mL at 24 hours after the initiation of Omidria administration, which may have been due to application of postoperative ketorolac ophthalmic solution.Reference ID: 3516266Omidria is a clear, colorless to slightly yellow, sterile solution concentrate with a pH of approximately 6.3.Each vial of Omidria contains:Actives: phenylephrine hydrochloride 12.4 mg/mL equivalent to 10.16 mg/mL of phenylephrine and ketorolac tromethamine 4.24 mg/mL equivalent to 2.88 mg/mL of ketorolac.Inactives: citric acid monohydrate; sodium citrate dihydrate; water for injection; may include sodium hydroxide and/or hydrochloric acid for pH adjustment.12 CLINICAL PHARMACOLOGY12.1 Mechanism of ActionThe two active pharmaceutical ingredients (API) in Omidria, phenylephrine and ketorolac, act tomaintain pupil size by preventing intraoperative miosis, and reducing postoperative pain.Phenylephrine is an 1-adrenergic receptor agonist and, in the eye, acts as a mydriatic agent by contracting the radial muscle of the iris. Ketorolac is a nonsteroidal anti-inflammatory that inhibits both cyclooxygenase enzymes (COX-1 and COX-2), resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma. Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, also prevents surgically induced miosis.12.3 PharmacokineticsIn a pharmacokinetic study evaluating Omidria, systemic exposure to both phenylephrine and ketorolac was low or undetectable.A single-dose of Omidria as part of the irrigation solution was administered in 14 patients during lens replacement surgery. The volume of irrigation solution used during surgery ranged between 150 mL to 300 mL (median 212.5 mL). Detectable phenylephrine plasma concentrations were observed in one of 14 subjects (range 1.2 to 1.4 ng/mL) during the first two hours after the initiation of Omidria administration. The observed phenylephrine plasma concentrations could not be distinguished from the preoperative administration of phenylephrine 2.5% ophthalmic solution prior to exposure to Omidria.Ketorolac plasma concentrations were detected in 10 of 14 subjects (range 1.0 to 4.2 ng/mL) during the first 8 hours after the initiation of Omidria administration. The maximum ketorolac concentration was 15 ng/mL at 24 hours after the initiation of Omidria administration, which may have been due to application of postoperative ketorolac ophthalmic solution.14 CLINICAL STUDIESThe efficacy and safety of Omidria were evaluated in two Phase 3, randomized, multicenter, double-masked, placebo-controlled clinical trials in 808 adult subjects undergoing cataract surgery or intraocular lens replacement.Subjects were randomized to either Omidria or placebo. Subjects were treated with preoperative topical mydriatic and anesthetic agents. Pupil diameter was measured throughout the surgical procedure. Postoperative pain was evaluated by self-administered 0-100 mm visual analog scales (VAS).Mydriasis was maintained in the Omidria-treated groups while the placebo-treated groups experienced progressive constriction.Figure 3: Intraoperative Pupil Diameter (mm) Change-from-BaselineMean Pupil Diameter (mm) Change From BaselinePlaceboOmidriaStudy 2PlaceboOmidriaStudy 10 5 10 15Minutes Since Start of Incision-1.5-1.0-0.50.0-1.5-1.0-0.50.0At the end of cortical clean-up, 23% of placebo-treated subjects and 4% of Omidria-treated subjects had a pupil diameter less than 6 mm (p < 0.01).Pain during the initial 10-12 hours postoperatively was statistically significantly less in the Omidria-treated groups than in the placebo-treated groups.Figure 4: Postoperative Mean Visual Analog Scale (VAS) Scores for PainMean VAS (mm) ScoreOmidriaPlaceboStudy 2OmidriaPlaceboStudy 12 4 6 8 10-12Hours Post Surgery051015051015During the 10-12 hours postoperatively, 26% of Omidria-treated subjects reported no pain (VAS = 0 at all timepoints) while 17% of placebo-treated subjects reported no pain (p < 0.01).16 HOW SUPPLIED/STORAGE AND HANDLINGOmidria is supplied as a sterile solution concentrate in a clear, 5-mL glass, single-patient-use vial containing 4 mL of sterile solution.Omidria is supplied in a multi-pack containing: 4 single-patient-use vials: NDC 62225-600-04 or 10 single-patient-use vials: NDC 62225-600-10Storage: Store at 20 to 25C (68 to 77F). Protect from light.17 PATIENT COUNSELING INFORMATIONInform patients that they may experience sensitivity to light.Omeros Corporation201 Elliott Avenue WestSeattle, WA 98119 Omeros 2013-2016 US Patents 8,173,707, 8,586,633, 9,066,856, and 9,278,101; additional patents pending. PI100016OMIDRIA and the OMIDRIA Logo are registered trademarks of Omeros Corporation.Revised: 05/2016References: 1. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2016. 2. Department of Health and Human Services. Centers for Medicare & Medicaid Services. MLN Matters. Number MM9014. 2014:1-19. 3. Kaiser Family Foundation analysis of the CMS Medicare Current Beneficiary Survey Cost and Use File, 2010. Visit www.omidria.com to learn more.Helpful resources* www.cms.gov ASC (Addendum BB) and HOPD (Addendum B) Payment Rates and Updates CMS Pass-Through Information CMS 2017 ASP Drug Pricing Files MLN Matters (MM9014)www.corcoranccg.com Corcoran Consulting Group OMIDRIA FAQ Corcoran Consulting Group OMIDRIA MonographOMEROS, the OMEROS logo, OMIDRIA, the OMIDRIA logo, and OMIDRIAssure are registered trademarks of Omeros Corporation. Omeros Corporation 2017, all rights reserved. 2017-040Please see Important Safety Information above and the Full Prescribing Information for OMIDRIA.IMPORTANT SAFETY INFORMATIONOMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% must be added to irrigation solution prior to intraocular use.OMIDRIA is contraindicated in patients with a known hypersensitivity to any of its ingredients.Systemic exposure of phenylephrine may cause elevations in blood pressure.Use OMIDRIA with caution in individuals who have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs), or have a past medical history of asthma.The most commonly reported adverse reactions at 2-24% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation.Use of OMIDRIA in children has not been established.Please see the Full Prescribing Information for OMIDRIA.You are encouraged to report Suspected Adverse Reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.For more information about OMIDRIA or to speak to a member of the Omeros Team, please call 1-844-OMEROS1 (1-844-663-7671)* Omeros Corporation does not guarantee the accuracy, completeness, or current status of information provided on third party web sites.

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